04 May, 2021

Process Engineer

  • Thermo Fisher Scientific
  • Plainville, MA, USA
Process Engineer Biochemicals / Pharmaceuticals Chemicals

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Thermo Fisher Scientific - Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

This role is based in the Greater Boston Area – Seated in Cambridge or Lexington in the interim, long term seated in new commercial facility in Plainville, MA. Approximately 20% travel to Alachua, FL and other local facilities

How will you make an impact?

The Process Engineer I will be responsible for supporting the new VVS facility in Plainville, MA with a scope encompassing process, analytical and laboratory equipment and systems for GMP manufacturing, process development, quality control, and warehouse operations. The initial focus of the position will be supporting the execution of a large capital facility project from detailed design, procurement and construction for a state-of-the-art new commercial manufacturing facility. This role will later transition into manufacturing operations support role in the site Facilities and Engineering team where they will support manufacturing, laboratory and warehouse operations in Plainville, MA. The position will be initially based remotely, or in Cambridge, MA or Lexington, MA sites during design/construction and will ultimately be based in Plainville, MA.

What will you do?

In operations, the Process Engineer I is responsible for the support of clinical and commercial drug manufacturing of gene therapy products. (S)he leads process engineering activities during tech transfers of new products into the manufacturing facility and provides continued support throughout manufacturing campaigns. The Process Engineer I also designs, specifies, and supports manufacturing equipment and analytical equipment including implementing modifications to improve operational performance and product quality. (S)he creates and maintains relationships with other VVS sites to develop and promote engineering best practices and ensures compliance with VVS SOP’s, safe work practices, and cGMP regulations. The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.

How will you get here?

Education

  • A B.S. degree in mechanical engineering, biochemical engineering, chemical engineering, electrical, automation engineering or related engineering field

Experience and Skills

  • 0-2 years of relevant experience or an equivalent combination of education, industry technical training and experience.
  • Direct experience supporting biologic manufacturing processes within an FDA/EMA regulated environment.
  • Experience/familiarity with cGMP process equipment and operations such as cell culture, bioreactors, filtration, chromatography, autoclaves, incubators, etc. is required.
  • Experience with single-use technologies is highly desirable.
  • The candidate must have an understanding of general cGMP standards and industry engineering best practices and be capable of leading user requirements definition, design, and procurement activities for manufacturing process equipment.
  • Working knowledge of equipment testing and associated protocols and lifecycle documentation requirements

 

 

Knowledge, Skills, Abilities

  • Strong interpersonal and communications skills; written and oral
  • Strong understanding of applicable regulatory requirements
  • Technical documentation review and revision experience
  • Working with both hands-on and remote based staff
  • Strong ability to work independently
  • Comfortable supporting concurrent issues and working in an exciting, fast-paced environment

 

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.


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